Financial Data and Key Metrics Changes - For Q1 2025, the company reported cash of $13.3 million, with an operating cash flow of $2.3 million, resulting in a monthly cash burn of approximately $800,000, down from $1.1 to $1.2 million last year [5][6] - The company forecasts a monthly cash burn of about $1 million for the remainder of the year, indicating a strong balance sheet with over a year of cash available [6] Business Line Data and Key Metrics Changes - The company is in the final stages of the verification and validation phase of its robotic system development, which has allowed for a reduction in variable costs [5] - The company has 27 full-time employees focused on ongoing R&D to achieve set milestones [5] Market Data and Key Metrics Changes - The orthopedic surgery market is highly consolidated, with Stryker holding a significant market share of approximately 70% with its Mako robot [15][16] - The company aims to capitalize on the generational shift in orthopedic surgery, as many new surgeons are being trained on robotic systems, which could lead to a significant market opportunity [17] Company Strategy and Development Direction - The company received FDA clearance for its embossed total TKA system, marking a significant milestone in its history [8][10] - The company plans to conduct a pilot placement with a major institution in the U.S. to demonstrate the system's value proposition and clinical performance [10] - The company is also preparing for a multicenter clinical trial in India, which will be the first clinical investigation involving autonomous robotic total knee surgeries on live patients [11][12] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future, highlighting the potential impact of robotic precision and efficiency in orthopedic surgeries [13][19] - The company believes it is at the forefront of a paradigm shift in orthopedic surgery, with plans to demonstrate its capabilities in live patient cases [14][19] Other Important Information - The company is actively showcasing its system with key opinion leaders and preparing for additional placements, emphasizing a slow and methodical rollout to ensure high service levels [11] - The company is exploring capital opportunities to accelerate growth, indicating a need for additional capital to support commercialization efforts [62] Q&A Session Summary Question: Can you provide more detail on timelines for the U.S. and India regarding technical and regulatory hurdles? - The company expects to perform live patient surgeries in India within 90 business days and anticipates the first placement in the U.S. to occur in Q2 or early Q3 [25][26] Question: What differentiators will allow Monogram to compete with Stryker? - The company aims to focus on accuracy, safety, and minimal surgeon fatigue, with plans to leverage AI for landmark identification and improve tensioning efficiency [31][33][39] Question: Can you provide more color on system enhancements? - Significant enhancements have been made to the feed rate and software of the robot, with ongoing internal testing to ensure safety and performance [50][51] Question: Is the domestic launch considered a trial or full commercial launch? - The launch is termed a pilot launch, allowing for real-world evaluation and surgeon training before broader commercialization [53][55] Question: What are the capital needs in light of upcoming clinical trials? - The company is actively exploring capital opportunities to accelerate growth, with strong interest from investors [62][63]

Financial Data and Key Metrics Changes - For Q1 2025, the company reported R&D expenses of $9.4 million, an increase from $6.8 million in the same period last year, primarily due to share-based compensation and higher clinical trial expenses related to the PHOENIX trial [22] - General and administrative expenses rose to $6.1 million from $1.6 million year-over-year, also attributed to share-based compensation [22] - The net loss for the quarter was $14.3 million, compared to a net loss of $7.9 million in the prior year [22] - Operating cash outflow was approximately $8.3 million, with a cash increase of $12.3 million for the quarter, leaving the company with $157.4 million in cash and equivalents at the end of Q1 [22] Business Line Data and Key Metrics Changes - The company is advancing its lead product, Tenereband, which is in global Phase III trials for Stargardt disease and geographic atrophy, with promising interim results reported [3][4] - The DRAGON trial for Stargardt disease has maintained its sample size at 104 subjects after an interim analysis, with a completion expected by the end of the year [4][12] - The PHOENIX trial for geographic atrophy has enrolled 464 subjects to date, with full enrollment of 500 expected in Q3 [5] Market Data and Key Metrics Changes - The company has received multiple designations for Tenereband, including rare pediatric disease and fast track designations in the US, and pioneer drug designations in Japan, highlighting the significant unmet need in the market [3][4] Company Strategy and Development Direction - The company is focused on advancing Tenereband as a potential first oral treatment for degenerative retinal diseases, with ongoing Phase III trials [6] - The strategy includes maintaining a strong balance sheet to support clinical trials, with expectations of a four-year cash runway [22] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the interim results from the DRAGON trial, indicating a trend for efficacy and a well-tolerated safety profile [12][41] - The company is monitoring regulatory changes and their potential impact on drug pricing strategies, particularly in the context of US and international markets [45] Other Important Information - The company reported a low dropout rate of approximately 20% in the PHOENIX trial, which is significantly lower than rates reported in other studies [30] - The interim analysis of the DRAGON trial indicated a withdrawal rate of less than 10%, with ocular adverse events being mild and transient [12][41] Q&A Session Summary Question: Can you provide data about the discontinuation rates and enrollment in the PHOENIX trial? - The dropout rate is approximately 20%, which is below rates reported in previous studies [30] Question: Any updates on regulatory meetings for Stargardt disease trial requirements? - Meetings with regulators are scheduled, but no updates are available at this time [33] Question: Thoughts on regulatory risk given changes at the FDA? - Management does not perceive any regulatory risk due to ongoing guidance from the FDA [38] Question: What is the goalpost for efficacy and safety in the Phase III data? - The study is powered to detect a 35% treatment effect between placebo and active [40] Question: Will operating expenses continue to rise during 2025? - Operating expenses are expected to be slightly higher than Q1 levels due to upcoming milestones in clinical studies [46] Question: How is the supply chain structured geographically? - Tenereband is manufactured in the US and other geographies, mitigating tariff impacts [56]

MDxHealth (MDXH) Q1 2025 Earnings Call May 14, 2025 04:30 PM ET Speaker0 note this event is being recorded. I would now like to turn the conference over to mister John Fernandez with LifeSci Advisors. Please go ahead. Speaker1 Good afternoon, and thank you for joining us for the MDX Health first quarter twenty twenty five earnings conference call. Joining me on today's call are Michael McGarity, Chief Executive Officer and Ron Kalpas, Chief Financial Officer. Before we begin, I would like to remind everyone ...

Financial Data and Key Metrics Changes - The company's net loss for Q1 2025 was $37 million, or $0.86 per share, compared to a net loss of $21.6 million, or $0.64 per share for Q1 2024 [21] - Non-GAAP adjusted net loss was $34.7 million, or $0.81 per share for Q1 2025, compared to a non-GAAP adjusted net loss of $19.9 million, or $0.59 per share for Q1 2024 [21] - Research and development expenses increased to $32.2 million in Q1 2025 from $20.6 million in Q1 2024, with a significant portion attributed to clinical trial activities [21][22] Business Line Data and Key Metrics Changes - The company is focused on three clinical programs, with expectations for significant revenue generation if regulatory approvals are achieved [6][7] - The VICTORIA-one trial is designed to evaluate gadotelisib in combination with fulvestrant, targeting patients with hormone receptor positive HER2 negative advanced breast cancer [8][10] - The VICTORIA-two trial is a global phase three study evaluating gadotelisib as a first-line treatment for similar patient populations [15][17] Market Data and Key Metrics Changes - The company estimates that nearly 200,000 late-stage cancer patients globally would be eligible for treatment with gadotelisib if approved [7] - The peak revenue potential for the second-line indication could exceed $2 billion with just 40% market penetration [15] Company Strategy and Development Direction - The company aims to transition to a commercial stage company following potential FDA approvals for its clinical programs [9][10] - There is a focus on addressing the significant unmet need for effective therapies in advanced breast cancer, particularly for patients resistant to endocrine therapy [17] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving key clinical milestones, including data readouts from ongoing trials in 2025 [6][9] - The company recognizes the importance of demonstrating clinically meaningful results in terms of progression-free survival (PFS) to gain acceptance among oncologists [12][14] Other Important Information - The company ended the quarter with approximately $205.7 million in cash, cash equivalents, and short-term investments, expected to fund clinical development activities through 2026 [22][23] - The company is collaborating with Dana Farber Cancer Institute and Massachusetts General Hospital to evaluate gadotelisib in endometrial cancer [19] Q&A Session Summary Question: Timing for data readout from VICTORIA-one trial - Management indicated that the primary completion date is expected in June, with data available in Q3 2025, and typically, the time from locking the database to reporting data is no more than three months [27][30] Question: Impact of SERNA6 on second-line treatment - Management believes SERNA6 will not affect their trial as it pertains to first-line CDK4/6 patients, and they expect physicians to continue treatment with gadotelisib if data is favorable [36][38] Question: Minimum hazard ratio for wild type update - Management stated that an incremental three months in PFS would be considered clinically meaningful, but they are not providing specific projections at this time [39][40] Question: Change in timing for wild type readout - Management clarified that the timing change is due to the complexity of the three-arm trial, but they are confident about the Q4 timeline for the PIK3CA mutant population [44][46] Question: Prior proof of concept data for prostate cancer - Management discussed the encouraging data for gadotelisib in prostate cancer and indicated that the update will focus on primary analysis and safety data, with further data to be reported at a medical meeting [48][52]

Journey Medical Corp (DERM) Q1 2025 Earnings Call May 14, 2025 04:30 PM ET Speaker0 Ladies and gentlemen, thank you for standing by. Good afternoon, and welcome to Journey Medical's First Quarter twenty twenty five Financial Results and Corporate Update Conference Call. At this time, all participants are in a listen only mode. Participants of this call are advised that the audio of this conference call is being broadcast live I would now like to turn the call over to Jacqueline Jaffe, the company's Senior D ...

Financial Data and Key Metrics Changes - Commission income increased by $154,000 or 4% to $4,200,000 in Q1 2025 compared to $4,100,000 in Q1 2024, reflecting organic growth across insurance distribution channels [12] - Net loss decreased by $3,600,000 or 68% to $1,700,000 in Q1 2025 versus $5,300,000 in Q1 2024, attributed to improved operational efficiency and reduced impairment charges [14] - Adjusted EBITDA improved significantly by 300% from a loss of $74,000 in Q1 2024 to a gain of $145,000 in Q1 2025, indicating a trend towards sustained profitability [14][15] Business Line Data and Key Metrics Changes - The launch of Reliance Auto Leasing is a significant development, allowing agency partners to offer vehicle leasing, which is expected to enhance client relationships and create a recurring revenue stream [8][9] - The acquisition of Spetner Associates is anticipated to expand market footprint and enhance agency network, contributing to revenue growth and margin improvement [9][10] Market Data and Key Metrics Changes - The company is focused on expanding its market share through innovative services and strategic acquisitions, positioning itself for scalable long-term growth [8][10] Company Strategy and Development Direction - The company emphasizes a disciplined financial approach and a streamlined operating model to enhance profitability and market presence [6][8] - Reliance Global Group is committed to innovation and disciplined growth, with a focus on expanding services for agency partners and increasing revenue opportunities [11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's trajectory towards scalable long-term growth, supported by new service offerings and strategic acquisitions [10][11] - The positive feedback from agents regarding new services indicates strong market acceptance and potential for future growth [9] Other Important Information - The company is nearing completion of the Bettner Associates acquisition, which is expected to create immediate cross-selling opportunities and enhance overall capabilities [9][10] Q&A Session Summary Question: Insights on the Septner acquisition benefits - The acquisition is expected to significantly increase EBITDA positivity and revenue, with potential for substantial cross-selling opportunities due to access to new insurance products [18][19] Question: Key drivers behind positive adjusted EBITDA - Positive adjusted EBITDA is driven by a combination of revenue growth, expense streamlining, and a focus on cost efficiency, with expectations for continued improvement through technology [20][21]

SeaStar Medical Holding (ICU) Q1 2025 Earnings Call May 14, 2025 04:30 PM ET Speaker0 Hello, and thank you for standing by. My name is Tiffany, and I will be your conference operator today. At this time, I would like to welcome everyone to the SeaStar Medical First Quarter Financial Results Conference Call. All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question and answer session. Thank you. I would now like to turn the call over to Jackie K ...

Oncolytics Biotech (ONCY) Q1 2025 Earnings Call May 14, 2025 04:30 PM ET Speaker0 Good afternoon, and welcome to OnClinic's Biotech's First Quarter Conference Call. All participants are now in listen only mode. There will be a question and answer session at the end of this call. Please be advised that this call is being recorded at the company's request. I would now like to turn the call over to John Pattern, Director of Investor Relations and Communication. Please go ahead. Speaker1 Thank you, operator. To ...

TMC the metals company (TMC) Q1 2025 Earnings Call May 14, 2025 04:30 PM ET Speaker0 be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker, Dave Krabzewski, Chief Financial Officer. Please go ahead, sir. Speaker1 Thank you, Michelle. Please note that during this call, statements made by the company will be forward looking and based on management's beliefs and assumptions from information available at this time. These statements are subject to know ...

scPharmaceuticals (SCPH) Q1 2025 Earnings Call May 14, 2025 04:30 PM ET Speaker0 a reminder, today's conference call is being recorded. I would now like to turn the conference over to Wim Thorpe, Investor Relations, to cover forward looking statements. Wim, please go ahead. Speaker1 Thank you, operator. Before beginning this afternoon's earnings call, we would like to highlight the following forward looking statements. All statements on this conference call, other than historical facts, are forward looking ...